CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report
Ureteral dilator recalled by Coloplast Manufacturing US
Coloplast Manufacturing US is recalling Ureteral dilator, distributed in 9 states. The recall was initiated on 11 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1463-2024
- FDA event ID
- 94218
- Recalling firm
- Coloplast Manufacturing US, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Mar 2024
- FDA classified
- 2 Apr 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 11 Mar 2024 | Recall initiated by company | |
| 2 Apr 2024 | Classified by FDA | +22 days |
| 10 Apr 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Ureteral dilator, REF RBD014
Where it was distributed
US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
ArizonaGeorgiaKansasLouisianaMarylandMinnesotaMississippiTennesseeWashington
Questions about this recall
Why was it recalled?
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
Which lots are affected?
UDI-DI: 03600040300503, Lot codes: 6885096, 6928493, 7036982, 7092593, 7148682, 7187751, 7275918, 7326750, 7362229, 7405815, 7424892, 7440816, 7459583, 7528743, 7575957, 7742150, 7806993, 7825256, 7874646, 7948615, 8050730, 8122897, 8174950, 8210399, 8313229, 8350283, 8359041, 8442175, 8519426, 8619976, 8700201, 8864944, 8946228, 8946264, 9122793, 9122794, 9168554, 9226390, 9246177, 9360599
Where was it sold?
US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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